MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE OFFSET CONNECTOR 5 MM

Model Number 02.07.0005

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 05/25/2020

Event Type  malfunction  

Manufacturer Narrative

Batch review performed by regulatory affairs department on 3 june 2020: lot 145743a: (b)(4) items manufactured and released on 11 october 2019.Expiration date: 2024-09-24.No anomalies found related to the problem.To date, (b)(4) item of the same lot has been sold without any similar reported event.Other device involved in the event: gmk hinge 02.07.10.9641 offset adapter 5mm lot 1856269.Batch review performed by medacta regulatory affairs department on 24 june 2020: lot 1856269: (b)(4) items manufactured and released on 16 january 2019.No anomalies found related to the problem.To date, no similar events reported on items of the same lot.

Event Description

When trying to assemble the offset onto the tibia, the offset does not come out of the instrument (offset adaptor), it stays in there and doesn't connect to the tibia.This has happened a few times and following the surgical technique correctly.Due to this case additional anesthesia was necessary and the surgery was prolonged of 10 minutes.

Manufacturer Narrative

Visual inspection performed by medacta r&d knee project manager: during the visual inspection to the internal o-ring and the three fixation teeth have been found damaged.However, these damages cannot be related to the failure of the implant offset insertion, whose cause remains unknown.Since we do not have the 5 mm implant offset available for evaluation and, since the 5 mm trial offset can be properly connected, we can not establish the real cause of the failure during the surgery.(the internal profile and surfaces of the offset connector and there are no visible signs of wear).

• Brand Name: GMK-HINGE OFFSET CONNECTOR 5 MM
• Type of Device: OFFSET CONNECTOR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10189421
• MDR Text Key: 197746763
• Report Number: 3005180920-2020-00349
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030815607
• UDI-Public: 07630030815607
• Combination Product (y/n): N
• PMA/PMN Number: K102437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 02.07.0005
• Device Catalogue Number: 02.07.0005
• Device Lot Number: 145743A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2020
• Date Manufacturer Received: 05/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 85